July 31, 2023 – Enrollment is opening for four clinical trials to evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing Monday. More clinical trials to test at least seven other treatments are expected to launch in the coming months.
The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are phase II, meant to test how safe the treatments are and how well they work.
But some advocates are concerned the process is still moving too slowly.
The Long COVID Alliance “is both encouraged and concerned by the announcement today from NIH,” the group said in a statement. “We welcome the NIH’s efforts to finally fund much needed and long overdue trials on long COVID. … Today's announcement unfortunately leaves many important questions unanswered and seems fraught with the same lack of transparency that has become all-to-familiar with RECOVER and its $1.15 billion budget.”
Long COVID patients have grown more frustrated about the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.
Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and co-lead of the RECOVER Initiative, said the agency is not sure exactly how many people have long COVID. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta,” he said during the briefing. Some estimates suggest 5% to 10% of those infected get long COVID. “I don’t think we have solid numbers as it’s a moving target,” Koroshetz said.
Here are details of the four trials:
- RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and results in the immune system not working properly. One treatment will test a longer dose of the antiviral Paxlovid (nirmatrelvir and ritonavir) now used to treat mild to moderate COVID-19 to keep it from becoming severe COVID.
- RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which is web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
- RECOVER-SLEEP will evaluate treatments for sleep issues, which can include daytime sleepiness and other problems. According to Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
- RECOVER-AUTONOMIC will evaluate treatments to help with symptoms linked with autonomic nervous system issues. The first trial will target a disorder known as POTS (postural orthostatic tachycardia syndrome), which can include an irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug used now to treat chronic heart failure will be tested.
Timelines
The first, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance reported by many with long COVID.
But the Long COVID Alliance said, again, that the NIH’s plan is lacking in details.
“The NIH has not presented a timeline for results: They have highlighted that enrollment will begin over the next several months, likely meaning that results to benefit many millions with Long COVID are still at least a year away,” the group said.
By then, long COVID will have been around for more than 4 years, “an unacceptable wait for patients to see meaningful results from this billion-dollar investment.”
Information on how to join long COVID trials is here.